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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K172038
Device Name Trocar
Applicant
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.
Tang Jiao Wang Street, Lilin Town
Zhongkai Hi-Tech Zone
Huizhou,  CN 516000
Applicant Contact Haobin Li
Correspondent
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.
Tang Jiao Wang Street, Lilin Town
Zhongkai Hi-Tech Zone
Huizhou,  CN 516000
Correspondent Contact Haobin Li
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/05/2017
Decision Date 10/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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